Terumo’s Perfusion System False Alarms: Company Issues Instructions

In short

Terumo’s Perfusion System has been playing up, issuing what turn out to be false alarms generated by the devices’ air bubble detection system. The company has issued guidance regarding what to do in the event of an alarm, together with some corrections to the user manual, but is not recalling the devices, nor suggesting withdrawal from use. Importantly they are not recommending stopping using the air bubble detection system.

Background

Terumo Cardiovascular Systems has issued what it calls a “Correction”, but could also be a Field Safety Notice in Europe, relating to some of its perfusion systems (Base for Terumo Advanced Perfusion System 1, catalogue number 801673, serial numbers 0011-1450). It seems devices have reportedly been issuing false alarms, to the extent that the company feels the need to issue this missive. Interestingly the “Correction” is tagged as a recall, despite the fact that the company is not requesting the return of any device, but merely issuing guidance and some new pages for the instruction manual.

The company states that previous corrective actions have seemingly not addressed this false alarm issue, so is now taking the step of warning that the alarm might happen. Importantly though, it is saying that incidences of false alarm remain rare.

The “Correction” can be found here and in essence it states that:

  • Affected products are Terumo’s Advanced Perfusion System 1, the Sarns™ Modular Perfusion System 8000 and the Sarns™ Perfusion System 9000.
  • The operator manual is being modified with information to alert users of the potential for false alarms and reinforce mitigation procedures in the event of such an alarm.

The company has received no reports of patient injury as a consequence of these alarms.

Source: Terumo Cardiovascular Systems Corporation.